A Phase 4 interventional study of Prednisone and Placebo in Facial Swelling, Tooth Position Anomalies and Tooth, Impacted, sponsored by University Magna Graecia. Completed at 1 site in Italy. Open to participants aged 18 Years to 32 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by University Magna Graecia · Phase 4, Interventional, and Treatment
The present study proposes to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus and pain after surgical removal of the mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.
This study aims to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus, and pain after surgical removal of M3M in a split-mouth randomized controlled clinical trial. Facial swelling will be evaluated using an innovative three-dimensional digital technique.
122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.
This study's enrollment of 34 is below the median of 70 across 88 interventional studies indexed under Tooth, Impacted.
Browse Tooth, Impacted studies →University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving a preoperative administration of prednisone 25 mg/os.
Drug: Prednisone
Patients receiving a preoperative administration of Placebo.
Drug: Placebo
Pre-operative drug administration before third molar surgery
Pre-operative Placebo administration before third molar surgery
Change in facial swelling
To compare the effectiveness of prednisone/os versus placebo in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) .
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Change in facial swelling
To compare the effectiveness of prednisone/os versus placebo in reducing facial swelling using quantitative three-dimensional analysis (differences are measured in cm3).
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Change in trismus
To assess the effects of prednisone/os administration on trismus (measured in cm)
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Change in pain with Visual analogue scale (VAS)
To assess the effects of prednisone/os administration on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome)
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Plan to share: No
Ran from Feb 2022 to primary completion in Oct 2022, 8 months.
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prednisone
University Magna Graecia